Recall Enforment Report D-0100-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Amerisource Health Services LLC, originally initiated on 11-14-2024 for the product Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories The product was recalled due to cgmp deviations: presence of n-nitroso-duloxetine impurity above the recommended interim limit. The product was distributed in Pa, Oh, Pr and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0100-202511-14-202412-11-2024Class II23,490 bottlesDuloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint LaboratoriesCGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limitOngoing
D-0099-202511-14-202412-11-2024Class II37,916 bottlesDuloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limitOngoing
D-0101-202511-14-202412-11-2024Class II8,561 bottlesDuloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limitOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68001-413Duloxetine Bluepoint
68001-414Duloxetine Duloxetine HydrochlorideCapsule, Delayed ReleaseOralBluepointHuman Prescription Drug
68001-415Duloxetine Bluepoint